The following data is part of a premarket notification filed by Reflow Medical with the FDA for Spex Support Catheter.
| Device ID | K141649 |
| 510k Number | K141649 |
| Device Name: | SPEX SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | REFLOW MEDICAL 1003 Calle Sombra San Clemente, CA 92673 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine REFLOW MEDICAL 1003 Calle Sombra San Clemente, CA 92673 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-20 |
| Decision Date | 2014-11-05 |
| Summary: | summary |